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Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUSII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00604903
First received: January 4, 2008
Last updated: February 16, 2017
Last verified: February 2012
January 4, 2008
February 16, 2017
August 23, 2006
February 2009   (Final data collection date for primary outcome measure)
Serious adverse events related to implantation or the device [ Time Frame: 6 ]
Primary Device Safety Objective: Serious Adverse Device Effects rate during 6 months following implantation (device or delivery system related) and Implantation related Serious Adverse Events rate during 6 months following implantation
Serious adverse events related to implantation or the device. [ Time Frame: 18 ]
Complete list of historical versions of study NCT00604903 on ClinicalTrials.gov Archive Site
Device accuracy [ Time Frame: 6 months ]

Compare accuracy of Remon Pressure Sensor with Millar catheter (invasive way of measuring pulmonary artery pressure).

Secondary end points included accuracy of the measured PA pressure, functionality of the system and evaluation of pressure readings at different postures.

Device accuracy [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
Remon CHF Medical Device Clinical Investigation PAPIRUS II: Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
The purpose of this study is to evaluate and document appropriate clinical safety and performance of the Remon CHF Implantable Pressure Sensor including the corresponding delivery system, the Remon CHF Home Unit, the Remon CHF Clinic System devices and associated application software. It is a small clinical trial to determine the feasibility of the device. The primary outcome measure relates to feasibility and not to health outcomes.

This study was a prospective feasibility, non-randomised, singlearm, multi-centre, interventional clinical investigation performed at 4 international sites. Patients were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system. Measurements were taken with the Remon CHF Home Unit and the Remon CHF Clinic System. Follow-up visits took place at one, three and six months after implant.

Per protocol, a minimum of 30 patients was required to demonstrate safety of the device.

The study was conducted in accordance with ISO 14155:2003 (parts I and II), the Declaration of Helsinki and all applicable local and national regulations in the countries of submission.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Masking Description:
No masking
Primary Purpose: Device Feasibility
Heart Failure
Device: Implant of Pressure sensor.
Implant of an Remon ImPressure implantable pulmonary artery pressure sensor utilizing the corresponding delivering system.
Experimental: Patients implanted with Pressure Sensor
Implant of Pressure sensor. These are patients, who were implanted with the Remon CHF Implantable Pressure Sensor utilizing the corresponding delivering system.
Intervention: Device: Implant of Pressure sensor.
Hoppe UC, Vanderheyden M, Sievert H, Brandt MC, Tobar R, Wijns W, Rozenman Y. Chronic monitoring of pulmonary artery pressure in patients with severe heart failure: multicentre experience of the monitoring Pulmonary Artery Pressure by Implantable device Responding to Ultrasonic Signal (PAPIRUS) II study. Heart. 2009 Jul;95(13):1091-7. doi: 10.1136/hrt.2008.153486. Epub 2009 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who exhibit signs and symptoms of NYHA Class III or IV heart failure.
  • Patients who are able to visit the clinic frequently during the 6 months following implantation.
  • Patients who are willing and able to perform all follow-up procedures.

Exclusion Criteria:

  1. Patients under the age of 18
  2. Pregnant women or women that plan to get pregnant during the study.
  3. Patients with, tricuspid or pulmonic stenosis, pulmonary stents, right sided mechanical heart valves
  4. Contraindication to antiplatelet therapy (aspirin and clopidogrel)
  5. Patients suffering from active infection (on antibiotic therapy)
  6. Known intracardiac mass (right atrial or right ventricular)
  7. Patients who have been implanted with a VAD
  8. Patients who are candidates for listing for heart transplantation if it is deemed that they have a possibility of receiving a heart within the next 6 months
  9. Patients that have lead implanted at the heart right side of the heart within the last 6 months
  10. Patients with any terminal illness, or with a life expectancy of less than 6 months
  11. Patients that are unable to lie flat for the duration of the procedure
  12. Patients that are unable to operate the home unit (due to physical or mental constrain)
  13. Patients after pneumonectomy
  14. Patients treated with oral anticoagulants INR > 1.5 prior to catheterization
  15. Patients with severe chronic renal failure (creatinine > 2.5 mg/dl)
  16. Patients suffered from acute myocardial infarction within the three months prior the study
  17. Patients that underwent open heart surgery within 4 weeks prior the study.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00604903
PAPIRUS II
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
No
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Horst Sievert, M.D. CardioVascular Center Frankfurt, Seckbacher
Boston Scientific Corporation
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP